Coronary guide catheter

ABSTRACT

Embodiments include an interventional guide catheter, comprising: a main tubular shaft with a distal tip and proximal end; the main tubular shaft comprising: a main inner structural layer comprising a metallic helically wound multi-filar wire extending from a proximal tube termination to a distal end, a braided wire layer covering the main inner structural layer that extends from the proximal tube termination to the distal end, an outer layer of polymer jacketing fixedly attached to the main inner structural layer and braid layer, an inner layer of polymer jacketing and fixedly attached to the main inner structural layer, a distal tip made of layers of polymer, a distal end curve shape for anatomical conformance that is heat processed in the main metal portion of the structure; and a lamination of the inner layer, main inner structural layer, braided wire layer and outer layer. Other embodiments are also included herein.

CLAIM OF PRIORITY

This application claims the benefit of priority to U.S. ProvisionalPatent Application Ser. No. 62/199,050, filed Jul. 30, 2015, which ishereby incorporated by reference herein in its entirety.

FIELD OF THE TECHNOLOGY

The present application relates to coronary guide catheters. Morespecifically, the present application relates to guide catheters thatare used to introduce therapeutic catheters, such as stent deliverysystems.

BACKGROUND

Interventional guide catheters are used by physicians to placecatheters, electrode leads and other therapeutic interventional devicesto desired locations in the patient's body. The guide catheter providessupport for device advancement (stents, balloons, etc.) for instance, tothe coronary arteries. It is the main conduit for therapeutic device andguide wire transport and provides a means for injecting contract media.Guide catheters typically have a pre-shaped distal end that isconfigured to allow access and direction into the arterial branches. Incoronary guide catheters, the distal end shapes also provide back-upsupport for device placement by using shapes made to “back-up” againstaortic anatomy.

Guide catheters are made so that the distal shapes as much as possible,retain their shape during the procedure and don't soften in bodytemperature to any significant or detrimental degree. Guide catheterswith distal end shapes also are typically made to provide end-to-endtorque to allow “steering” the distal end into the artery. In addition,guide catheter are typically made to be relatively stiff so that thereis no stretching and biasing during device passage. To achieve theseperformance criteria, current guide catheter construction means areusually polymer based with metallic wire braid reinforcement.

The problems associated with current interventional guide cathetersinclude softening at body temperature thereby losing criticalperformance features like back-up support or torsion. In addition, guidecatheters have been prone to kinking, buckling, ovaling and stretching,especially in long procedures or difficult, more tortuous anatomy.

SUMMARY

Embodiments disclosed herein include an interventional guide catheterfor introducing interventional catheters into the vasculature,comprising: a main tubular shaft with a distal tip and proximal end; themain tubular shaft comprising: a main inner structural layer comprisinga metallic helically wound multi-filar wire (wall thickness(0.0015-0.010″) extending from a proximal tube termination to the distalend, a braided wire layer (0.0005-0.010″ thick) covering the metallichelically wound multi-filar layer that extends from the proximal tubetermination to the distal end, an outer layer of polymer jacketingcovering and fixedly attached to the main metal structure and braidlayer with wall thickness of 0.001-0.005″, an inner layer of polymerjacketing covering and fixedly attached to the inner metal structurewith wall thickness of 0.001-0.0005″, a distal tip made of layers ofpolymer, the distal tip being 0.05-0.20″ in length, an optional distalend curve shape for anatomical conformance that is heat processed in themain metal portion (e.g., one or more of the multi-filar layer, braid orthe like) of the structure; and a lamination of the inner layer,metallic helically wound multi-filar layer, braid and outer layer thatoptionally does not comprise fusion of the outer and inner layers. Themain metal portion is separately heat processed (e.g., to provide thedistal end curve shape) prior to lamination in one example. In anotherexample, the main metal portion is heat processed while incorporatedwith the other components of the catheter (e.g., the inner and outerlayers, or the like).

In an embodiment, the main helically wound multi-filar layer terminatesdistally before the primary curve of the distal end. In anotherembodiment, the main helically wound layer terminates proximal to thedistal end curve shape including the primary curve.

In an embodiment, the outer and inner layers are fused together throughthe main coil structure and braid.

In an embodiment, the metal helically wound multi-filar layer comprisesstainless steel.

In an embodiment, the braid layer comprises stainless steel wire.

In an embodiment, the multi-filar structure comprises at least 6 filarsand not more than 20 filars.

In an embodiment, the multi-filar structure wire has been swaged.

In an embodiment, the outer diameter of the main tubular shaft is atleast 0.060 inches and not more than 0.115 inches.

In an embodiment, the outer layer comprises Pebax.

In an embodiment, the outer layer comprises nylon.

In an embodiment, the outer layer is coated with a hydrophilic polymer.

In an embodiment, the inner layer comprises PTFE.

In an embodiment, the inner layer comprises nylon.

In an embodiment, the inner layer is coated with a hydrophilic polymer.

In an embodiment, the distal tip comprises a PTFE inner layer and aPebax outer layer.

In an embodiment, the metallic helically wound layer comprises weldedterminations.

In an embodiment, the metallic helically wound layer comprises a distalend that comprises a gold coating.

In an embodiment, the gold coating is at least 0.5 mm and not more than2 mm in length.

In an embodiment, the outer layer comprises at least two layers ofPebax.

In an embodiment, the outer layer is heat shrinkable to allow it to beformed tightly onto the metallic helically wound layer.

In an embodiment, the metallic helically wound wire has a rectangularcross-section.

In an embodiment, the metallic helically wound wire has a circularcross-section.

In an embodiment, the metallic helically wound layer wire has an oval orelliptical cross-section.

In an embodiment, the metallic helically wound layer wire has beencoated with PTFE coating prior to forming into the multi-filarconfiguration.

In an embodiment, the main tubular shaft length is at least 60 cm andnot more than 200 cm long.

This summary is an overview of some of the teachings of the presentapplication and is not intended to be an exclusive or exhaustivetreatment of the present subject matter. Further details are found inthe detailed description and appended claims. Other aspects will beapparent to persons skilled in the art upon reading and understandingthe following detailed description and viewing the drawings that form apart thereof, each of which is not to be taken in a limiting sense. Thescope of the present application is defined by the appended claims andtheir legal equivalents.

BRIEF DESCRIPTION OF THE FIGURES

The technology may be more completely understood in connection with thefollowing drawings, in which:

FIG. 1 is a front view of a guide catheter, according to an embodiment.

FIG. 2 is a back view of a guide catheter, according to an embodiment.

FIG. 3 is a cross-section view of a guide catheter, according to anembodiment.

FIG. 4 is a cross-section view of a portion of a guide catheter,according to an embodiment.

FIG. 5 is a cross-section view of a portion of a guide catheter,according to an embodiment.

FIG. 6 is a cross-section view of a portion of a guide catheter,according to an embodiment.

FIG. 7 is a cross-section view of a portion of a guide catheter,according to an embodiment.

FIG. 8 is a cross-section view of a portion of a guide catheter,according to an embodiment.

FIG. 9 is a cross-section view of a portion of a guide catheter,according to an embodiment.

FIG. 10 is a front view of a guide catheter, according to an embodiment.

While the technology is susceptible to various modifications andalternative forms, specifics thereof have been shown by way of exampleand drawings, and will be described in detail. It should be understood,however, that the application is not limited to the particularembodiments described. On the contrary, the application is to covermodifications, equivalents, and alternatives falling within the spiritand scope of the technology.

DETAILED DESCRIPTION

The embodiments of the present technology described herein are notintended to be exhaustive or to limit the technology to the preciseforms disclosed in the following detailed description. Rather, theembodiments are chosen and described so that others skilled in the artcan appreciate and understand the principles and practices of thepresent technology.

All publications and patents mentioned herein are hereby incorporated byreference. The publications and patents disclosed herein are providedsolely for their disclosure. Nothing herein is to be construed as anadmission that the inventors are not entitled to antedate anypublication and/or patent, including any publication and/or patent citedherein.

The guide catheter as described herein can solve the problems associatedwith current guide catheter technology by providing a novel design,construction and materials.

The guide catheter, described herein, can be used in interventionalcases where significant arterial tortuosity is encountered such as usinga radial artery access or using a femoral approach on an obese patient.

In various embodiments, the guide catheter can include a composite builttube that can be fabricated using a specially wound metal inner layerand jacketed with very thin layers of polymer inside and out. Themetallic inner layer can be made using a multi-filar (6-20 filars)helically wound wire structure. In some embodiments, the helicalstructure can be swaged, such that each individual wire strand ispartially rectangular in cross-section and therefore can result in avery tight/close fitting wire matrix. The helical structure can also bemade using a non-swaged, round, square or rectangular wire.

In various embodiments, the wall thickness of the inner metal structurecan range from 1.5 to 10 thousandths of an inch thick.

The helically wound metal structure can improve the mechanical integrityof the catheter tube, such as compared to current guide catheters withrespect to kinking, buckling, flexibility, radial strength, andmaintaining circularity of the catheter lumen cross-section.

This marked improvement can be achieved by the significant increase inthe amount of metal in the catheter. For instance, current guidecatheters that are composite built or wire braid reinforced have totalcross-sectional metallic component in the range of 5-10%. The guidecatheter as described herein can have a total cross-sectional metalliccomponent of 40-60%. The transmission of mechanical energy through thissignificantly higher modulus composite can result in significantlyhigher performance.

The guide catheter of this invention also comprises an outer polymerlayer and an inner polymer layer. In an embodiment, the outer polymerlayer and the inner polymer layer can include one or more polymers, suchas PTFE, Pebax, or Polyurethane. The polymer layers can be attached tothe metal structure by thermal polymer heat-shrinking or reflow. Theresultant wall thickness of the polymer layers can range from 0.5 to 3.0thousandths of an inch for each layer.

In various embodiments, the guide catheter can include a pre-shapedcurve, such as a curved distal end region. The guide catheter can attainthe pre-shaped curve configuration by heat-setting the metal in thisportion of the catheter. The result can include a curve that retains itsshape in body temperature and over time does not substantially soften,such as soften enough to unintentionally change shape.

The guide catheter can further include a soft (low durometer) polymerdistal tip, various distal curve shapes, a radiopaque distal markerband, and a proximal luer adapter.

The guide catheter range in sizes from 4 F to 8 F and in lengths from 80to 125 cm.

In reference now to the figures, FIG. 1 shows a front view of a guidecatheter 100, according to an embodiment. FIG. 2 shows a back view ofthe guide catheter 100. FIG. 3 shows a cross-sectional view of the guidecatheter 100. In an embodiment, the guide catheter 100 can be configuredfor introducing interventional catheters into the vasculature of apatient.

In an embodiment, the catheter 100 can include a main tubular shaft 102with a distal tip 104 and proximal end 106. The distal tip 104 can be onthe opposite end of the tubular shaft 102 from the proximal end 106. Thedistal tip 104 can include at least one layer of polymer. In anembodiment, the distal tip 104 includes at least two layers of polymer.In an embodiment, the distal tip 104 can include an inner layer and anouter layer. In an embodiment, the inner layer of the distal tip 104 caninclude PTFE. In an embodiment, the outer layer of the distal tip 104can include Pebax.

In an embodiment, the distal tip 104 can be at least 0.05 inches long.In an embodiment, the distal tip 104 can be at least 0.02 inches long.In an embodiment, the distal tip 104 can be 0.2 inches long or shorter.In an embodiment, the distal tip 104 can be 0.5 inches long or shorter.In various embodiments, the tubular shaft 102 can include a main innerstructural layer.

The main inner structural layer can include a metallic helically woundmulti-filar wire extending from a proximal tube termination (e.g., theproximal shaft end 106 or proximal shaft portion 108) to a distal end112 including at least the bracketed 112 shown in FIGS. 1-3 (e.g., atthe distal location). The main inner structural layer can furtherinclude a braided wire layer. In various embodiments, the braided wirelayer can cover at least a portion of the outer portion (opposite fromthe inner lumen) of the metallic helically wound multi-filar layer thatextends from the proximal tube termination to the distal end. In otherembodiments, the braided wire layer is within the metallic helicallywound multi-filar layer.

In various embodiments, the main tubular shaft 102 can include an outerlayer. The outer layer can include a polymer. The outer layer canjacket, coat, or cover the outer surface of the main inner structurallayer. The outer layer can be fixedly attached to the main innerstructural layer.

In various embodiments, the main tubular shaft 102 can include an innerlayer. The inner layer can include a polymer. The inner layer canjacket, coat, or cover the inner surface of the main inner structurallayer. The inner layer can be fixedly attached to the main innerstructural layer.

The main tubular shaft 102 can include a curve, such as on the distalend (shown in FIG. 10). The curve shape can be configured for anatomicalconformance. The shape can be heat processed in the main tubular shaft102, such as in the main inner structural layer or another metalportion. In an embodiment, the helically wound multi-filar layerterminates distally prior to the curve of the distal end. In anotherembodiment the helically wound multi-filar layer terminates proximal aprimary curve of the curve (e.g., of the distal end curve shape) anddistal to other portions of the curve including, but not limited tosecondary and tertiary curves.

In various embodiments, the metallic helically wound multi-filar layer,and the braid can be laminated by the inner layer and the outer layer,such that the lamination does not fuse the outer layer and the innerlayer together.

In an embodiment, the main tubular shaft 102 can be at least 60 cm longand not longer than 200 cm. In an embodiment, the main tubular shaft 102can be at least 10 cm long and not longer than 300 cm. In an embodiment,the main tubular shaft 102 can be at least 30 cm long and not longerthan 250 cm. In an embodiment, the main tubular shaft 102 can be atleast 50 cm long and not longer than 225 cm.

In an embodiment, the main tubular shaft 102 can have an outer diameterof at least 0.060 inches and not more than 0.115 inches. In anembodiment, the main tubular shaft 102 can have an outer diameter of atleast 0.060 inches. In an embodiment, the main tubular shaft 102 canhave an outer diameter of at least 0.040 inches. In an embodiment, themain tubular shaft 102 can have an outer diameter of at least 0.050inches. In an embodiment, the main tubular shaft 102 can have an outerdiameter of at least 0.070 inches. In an embodiment, the main tubularshaft 102 can have an outer diameter of at least 0.080 inches.

In an embodiment, the main tubular shaft 102 can have an outer diameterof no greater than 0.115 inches. In an embodiment, the main tubularshaft 102 can have an outer diameter of no greater than 0.095 inches. Inan embodiment, the main tubular shaft 102 can have an outer diameter ofno greater than 0.105 inches. In an embodiment, the main tubular shaft102 can have an outer diameter of no greater than 0.125 inches. In anembodiment, the main tubular shaft 102 can have an outer diameter of nogreater than 0.135 inches.

FIG. 4 and FIG. 5 show cross-section views of portions of a guidecatheter 100, according to various embodiments. FIG. 5 shows across-section of a portion of the distal tip 104. As seen in FIG. 5, theguide catheter 100 can define one or more apertures 506. In variousembodiments, the main tubular shaft 102 can define an aperture 506. Inan embodiment, the distal tip 104 can define an aperture 506.

FIG. 6 shows a cross-section view of a portion of the main tubular shaft102, according to an embodiment. FIG. 7 shows a cross-section view fromthe end of the main tubular shaft 102. In an embodiment, the maintubular shaft 102, can include a main inner structural layer 608. Themain inner structural layer 608 can include a metallic helically woundmulti-filar wire. In various embodiments, the metallic helically woundmulti-filar wire can include stainless steel. In various embodiments,the metallic helically wound multi-filar wire can be swaged.

In various embodiments, the metallic helically wound multi-filar wirecan include at least 6 filars and not more than 20 filars. In variousembodiments, the metallic helically wound multi-filar wire can includeat least 4 filars and not more than 24 filars. In various embodiments,the metallic helically wound multi-filar wire can include at least 8filars and not more than 18 filars. In various embodiments, the metallichelically wound wire can have a rectangular cross-section, a circularcross-section, an oval cross-section or an elliptical cross-section. Invarious embodiments, the metallic helically wound wire can have beensubstantially coated with PTFE coating prior to forming into themulti-filar configuration.

In an embodiment, the main inner structural layer 608 can include weldedterminations. In an embodiment, the main inner structural layer 608 caninclude a distal end that includes a gold coating. In variousembodiments, the gold coating can range from 0.5 mm thick to 2 mm inlength. In various embodiments, the gold coating can range from 0.4 mmthick to 2.5 mm in length. In various embodiments, the gold coating canrange from 0.25 mm thick to 3 mm in length.

In an embodiment, the main inner structural layer 608 can have athickness that can range from 0.0015 inches to 0.010 inches (e.g., oneor more of a consistent thickness or variable thicknesses). In anembodiment, the main inner structural layer 608 can have a thickness ofat least 0.0010 inches. In an embodiment, the main inner structurallayer 608 can have a thickness of at least 0.0005 inches. In anembodiment, the main inner structural layer 608 can have a thickness ofno greater than 0.015 inches. In an embodiment, the main innerstructural layer 608 can have a thickness of no greater than 0.020inches. Optionally, the main inner structural layer 608 includes avarying wall thickness. For instance, the metallic helically woundmulti-filar wire is ground so that portions of the layer have varyingthickness. The catheter, in some examples includes corresponding reduceddiameter based on the grinding of the metallic helically woundmulti-filar wire. In still another example, the metallic helically woundmulti-filar wire is formed with a varied diameter (e.g., is necked) toaccordingly decrease the thickness of the main inner structural layer608. In one example, a proximal portion of the main inner structurallayer 608 includes a greater thickness relative to a distal portion toenhance pushability of the catheter. In another example, the distalportion of the main inner structural layer 608 has a lesser thicknessthan the proximal portion to facilitate bending and correspondingnavigation through tortuous vasculature. In an embodiment, the maintubular shaft 102 can include an outer layer 610. The outer layer 610can include a polymer. The outer layer 610 can jacket or cover at leasta portion of the outer portion of the main inner structural layer 608.In an embodiment, the outer layer 610 can be at least 0.001 inches thickand not more than 0.005 inches thick. In an embodiment, the outer layer610 can be at least 0.0007 inches thick. In an embodiment, the outerlayer 610 can be at least 0.0005 inches thick. In an embodiment, theouter layer 610 can be no more than 0.007 inches thick. In anembodiment, the outer layer can be no more than 0.01 inches thick.

In an embodiment, the outer layer 610 can include Pebax. In anembodiment, the outer layer 610 can include nylon. In an embodiment, theouter layer 610 can be coated with a hydrophilic polymer. In anembodiment, the outer layer 610 can include at least two layers. In anembodiment, each of the two layers included in the outer layer 610 caninclude Pebax. In various embodiments, the outer layer 610 can be heatshrinkable, such as to allow the outer layer 610 to be formed tightlyonto the main inner structural layer 608.

In an embodiment, the main tubular shaft 102 can include an inner layer612. The inner layer 612 can include a polymer. The inner layer 612 canjacket or cover at least a portion of the inner portion of the maininner structural layer 608. In an embodiment, the inner layer 612 can beat least 0.001 inches thick and not more than 0.005 inches thick. In anembodiment, the inner layer 612 can be at least 0.0007 inches thick. Inan embodiment, the inner layer 612 can be at least 0.0005 inches thick.In an embodiment, the inner layer 612 can be no more than 0.007 inchesthick. In an embodiment, the inner layer can be no more than 0.01 inchesthick.

In an embodiment, the inner layer 612 can include PTFE. In anembodiment, the inner layer 612 can include nylon. In an embodiment, theinner layer 612 can be coated with a hydrophilic polymer.

In an embodiment, the outer layer 610 and the inner layer 612 can befused together, such as through the main inner structural layer 608and/or the braid 814 (shown in FIG. 8).

FIG. 8 shows a cross-section view of a portion of the main tubular shaft802, according to an embodiment. FIG. 9 shows a cross-section view fromthe end of the main tubular shaft 802.

In various embodiments, the main tubular shaft 802 can include a braidedwire layer 814. In an embodiment, the braided wire layer 814 can bedisposed between the main inner structural layer 808 and the outer layer810. In an embodiment, the braided wire layer 814 can be disposed withina portion of the outer layer 810. In another embodiment, the braidedwire layer 814 is provided within the main inner structural layer 808(e.g., along the interior of the layer 808). Optionally, the braidedwire layer 814 is between the inner layer 812 and the main innerstructural layer 808.

The braided wire layer 814 can cover at least a portion of the maininner structural layer 808, such as the helically wound multi-filarlayer. In an embodiment, the braided wire can include stainless steel.

In an embodiment, the braided wire layer 814 can be at least 0.0005inches thick and not more than 0.010 inches thick. In an embodiment, thebraided wire layer 814 can be at least 0.005 inches thick and not morethan 0.010 inches thick.

In an embodiment, the braided wire layer 814 can be at least 0.0004inches thick. In an embodiment, the braided wire layer 814 can be atleast 0.0003 inches thick. In an embodiment, the braided wire layer 814can be no more than 0.015 inches thick. In an embodiment, the braidedwire layer 814 can be no more than 0.020 inches thick.

FIG. 10 shows a front view of a guide catheter 1000, according to anembodiment. In an embodiment, the guide catheter 1000 can include adistal end curve 1016. The distal end curve 1016 can be configured foranatomical conformance. The distal end curve 1016 can be heat processedin the metal portion of the catheter 1000. In an embodiment, the mainhelically wound layer can terminate distally before a primary curve(e.g., one or more of curves 1018, 1020, 1022 or the like) of the distalend 112.

In various embodiments, the guide catheter can include a pre-shapedcurve, such as a curved distal end region. The guide catheter can attainthe pre-shaped curve configuration by heat-setting the metal in thisportion of the catheter. The result can include a curve that retains itsshape in body temperature and over time does not substantially soften,such as soften enough to unintentionally change shape.

It should be noted that, as used in this specification and the appendedclaims, the singular forms “a,” “an,” and “the” include plural referentsunless the content clearly dictates otherwise. Thus, for example,reference to a composition containing “a compound” includes a mixture oftwo or more compounds. It should also be noted that the term “or” isgenerally employed in its sense including “and/or” unless the contentclearly dictates otherwise.

It should also be noted that, as used in this specification and theappended claims, the phrase “configured” describes a system, apparatus,or other structure that is constructed or configured to perform aparticular task or adopt a particular configuration to. The phrase“configured” can be used interchangeably with other similar phrases suchas arranged and configured, constructed and arranged, constructed,manufactured and arranged, and the like.

All publications and patent applications in this specification areindicative of the level of ordinary skill in the art to which thistechnology pertains. All publications and patent applications are hereinincorporated by reference to the same extent as if each individualpublication or patent application was specifically and individuallyindicated by reference.

The technology has been described with reference to various specific andpreferred embodiments and techniques. However, it should be understoodthat many variations and modifications may be made while remainingwithin the spirit and scope of the technology.

1. An interventional guide catheter for introducing interventionalcatheters into the vasculature, comprising: a main tubular shaft with adistal tip and proximal end; the main tubular shaft comprising: a maininner structural layer comprising a metallic helically wound multi-filarwire extending from a proximal tube termination to a distal end, themulti-filar wire having a wall thickness of 0.0015 to 0.010 inches, abraided wire layer covering the main inner structural layer that extendsfrom the proximal tube termination to the distal end, the braided wirelayer having a thickness of 0.0005 to 0.010 inches, an outer layer ofpolymer jacketing covering and fixedly attached to the main innerstructural layer and braid layer with wall thickness of 0.001 to 0.005inches, an inner layer of polymer jacketing covering and fixedlyattached to the main inner structural layer with wall thickness of 0.001to 0.0005 inches, a distal tip made of layers of polymer, the distal tipbeing 0.05-0.20 inches in length, a distal end curve shape foranatomical conformance formed by the main inner structural layer; and alamination of the inner layer, main inner structural layer, braided wirelayer and outer layer with the inner layer spaced from the outer layer.2. The guide catheter of claim 1, wherein the main helically wound layerterminates distally before a primary curve of the distal end curveshape.
 3. The guide catheter of claim 1, wherein the outer and innerlayers are fused together through one or more of the main innerstructural layer or the braided wire layer.
 4. The guide catheter ofclaim 1, wherein the lamination does not comprise fusion of the outerand inner layers.
 5. The guide catheter of claim 1, wherein the metallichelically wound multi-filar wire comprises stainless steel.
 6. The guidecatheter of claim 1, wherein the braided wire layer comprises stainlesssteel wire.
 7. The guide catheter of claim 1, wherein the main innerstructural layer comprises at least 6 filars and not more than 20filars.
 8. The guide catheter of claim 1, wherein the metallic helicallywound multi-filar wire has been swaged.
 9. The guide catheter of claim1, wherein an outer diameter of the main tubular shaft is at least 0.060inches and not more than 0.115 inches.
 10. The guide catheter of claim1, wherein the outer layer comprises Pebax.
 11. The guide catheter ofclaim 1, wherein the outer layer comprises Nylon.
 12. The guide catheterof claim 1, wherein the outer layer is coated with a hydrophilicpolymer.
 13. The guide catheter of claim 1, wherein the inner layercomprises PTFE.
 14. The guide catheter of claim 1, wherein the innerlayer comprises Nylon.
 15. The guide catheter of claim 1, wherein theinner layer is coated with a hydrophilic polymer.
 16. The guide catheterof claim 1, wherein the distal tip comprises a PTFE inner layer and aPebax outer layer.
 17. The guide catheter of claim 1, wherein the maininner structural layer comprises welded terminations.
 18. The guidecatheter of claim 1, wherein the main inner structural layer comprises adistal end that comprises a gold coating.
 19. The guide catheter ofclaim 18, wherein the gold coating is at least 0.5 mm and not more than2 mm in length.
 20. The guide catheter of claim 1, wherein the outerlayer comprises at least two layers of Pebax.
 21. The guide catheter ofclaim 1, wherein the outer layer is heat shrunk around the the maininner structural layer.
 22. The guide catheter of claim 1, wherein themetallic helically wound multi-filar wire has a rectangularcross-section.
 23. The guide catheter of claim 1, wherein the metallichelically wound multi-filar wire has a circular cross-section.
 24. Theguide catheter of claim 1, wherein the metallic helically woundmulti-filar wire has an oval or elliptical cross-section.
 25. The guidecatheter of claim 1, wherein the metallic helically wound multi-filarwire has been coated with PTFE coating prior to forming the main innerstructural layer.
 26. The guide catheter of claim 1 wherein the maintubular shaft length is at least 60 cm and not more than 200 cm long.